Professional Documents
Culture Documents
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1. Scope
1.1 General
This International Standard specifies requirements for a quality
management system where an organization.
a)
b)
1.2 Application
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2. Normative reference
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For the purpose of this document, the terms and definitions given
in ISO 9000 apply.
Throughout the text of this International Standard, wherever the
term product occurs, it can also mean service
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e)
f)
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b)
A quality manual,
c)
d)
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b)
c)
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Documents required by the quality management system shall be controlled. Records are a special
type of document and shall be controlled according to the requirements given in 4.2.4
A documented procedure shall be established to define the controls needed,
a)
b)
c)
To ensure that changes and the current revision status of documents are identified,
d)
To ensure that relevant versions of applicable documents are available at points of use,
e)
f)
g)
To prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose.
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5. Management Responsibility
5.1 Management commitment:
Top management shall provide evidence of its commitment to the
development and implementation of the quality management
system and continually improving its effectiveness by
a)
b)
c)
d)
e)
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b)
c)
d)
e)
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5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those
needed to meet requirements for product [see 7.1], are established at
relevant functions and levels within the organization. The quality
objectives shall be measurable and consistent with the quality policy.
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Results of audits
Customer feedback,
Process performance and product conformity,
Status of preventive and corrective actions,
Follow up actions from previous management reviews,
Changes that could affect the quality management system,
and
Recommendation for improvement.
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6. Resource Management
6.1 Provision of resources
b)
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b)
c)
d)
Ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives,
and
e)
6.3 Infrastructure
The organization shall determine, provide and maintain the
infrastructure needed to achieve conformity to product
requirements, infrastructure includes, as applicable,
a)
b)
c)
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7. Product Realization
7.1 Planning of product realization
The organization shall plan and develop the processes needed for product
realization. Planning of product realization shall be consistent with the
requirements of the other processes of the quality management
system (see 4.1)
In Planning product realization, the organization shall determine the
following, as appropriate:
a)
b)
c)
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b)
c)
d)
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b)
c)
Records of the results of the review and actions arising from the
review shall be maintained (see 4.2.4).
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Continuation of 7.2.2
Where the customer provides no documented statement of
requirement, the customer requirements shall be confirmed
by the organization before acceptance.
Where product requirements are changed, the organization shall
ensure that relevant documents are amended and that
relevant personnel are made aware of the changed
requirements.
NOTE: In some situations, such as internet sales, a formal review
is impractical for each order. Instead the review can cover
relevant product information such as catalogues or
advertising material.
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Product information,
b)
c)
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